FDA product code LEH: Radioimmunoassay, Vancomycin
LEH is the FDA product code for radioimmunoassay, vancomycin. It is a Class II device, regulated under 21 CFR 862.3950 and reviewed by the Clinical Toxicology panel. FDA has cleared 31 510(k) submissions under LEH, 1 in the last five years, from 24 different applicants. The average 510(k) review took 88 days (median 65). FDA has posted 12 recalls for LEH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Vancomycin |
| Device class | Class II |
| Regulation | 21 CFR 862.3950 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 361 |
Compare with all 510(k) review times · Search every LEH clearance
Top LEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 4 | 1996-05-09 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2023-08-08 |
| Biokit, S.A. | 2 | 2013-08-29 |
| Roche Diagnostic Systems, Inc. | 2 | 1995-09-12 |
| Innotron of Oregon, Inc. | 2 | 1990-04-19 |
19 more applicants have LEH clearances. See the full list in Caduvo.
Most recent LEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222439 | Siemens Healthcare Diagnostics, Inc. | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | 2023-08-08 | 361 |
| K160202 | Siemens Healthcare Diagnostics, Inc. | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | 2016-04-27 | 90 |
| K152245 | Roche Diagnostics Operations (Rdo) | ONLINE TDM Vancomycin Gen.3 | 2016-01-08 | 151 |
| K123947 | Biokit, S.A. | ARCHITECT IVANCOMYCIN | 2013-08-29 | 251 |
| K072036 | Biokit, S.A. | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 | 2008-03-19 | 238 |
Recalls for LEH devices
12 product recalls in 11 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LEH?
LEH is the FDA product code for radioimmunoassay, vancomycin. It is a Class II device, regulated under 21 CFR 862.3950 and reviewed by the Clinical Toxicology panel.
What device class is LEH?
Class II, regulation 21 CFR 862.3950. Typical premarket route: 510(k).
How long does a 510(k) take for product code LEH?
Across 31 cleared submissions the average was 88 days from receipt to decision (median 65).
Which companies have the most LEH clearances?
Abbott Laboratories (4); Siemens Healthcare Diagnostics, Inc. (2); Biokit, S.A. (2); Roche Diagnostic Systems, Inc. (2); Innotron of Oregon, Inc. (2).
Have LEH devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LEH
- Run a recall and safety report across every LEH manufacturer
- Watch product code LEH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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